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Abstract:

Described herein are systems and methods from delivering prosthetic
devices, such as prosthetic heart valves, through the body and into the
heart for implantation therein. The prosthetic devices delivered with the
delivery systems disclosed herein are, for example, radially expandable
from a radially compressed state mounted on the delivery system to a
radially expanded state for implantation using an inflatable balloon of
the delivery system. Exemplary delivery routes through the body and into
the heart include transfemoral routes, transapical routes, and
transaortic routes, among others.

Claims:

1. A delivery device for implantation of a prosthetic device within the
body, the prosthetic device being radially expandable from a radially
compressed state to a radially expanded state, the delivery device
comprising: an inflatable balloon; and a proximal stop and a distal stop
configured to limit longitudinal movement of the prosthetic device
relative to the balloon while the prosthetic device is mounted over the
balloon in the radially compressed state between the proximal stop and
the distal stop; wherein the proximal stop and the distal stop each
comprise an end portion positioned within the balloon and configured to
be positioned adjacent a respective end of the prosthetic device when the
prosthetic device is radially compressed between the proximal and distal
stops, each of the end portions comprising at least one longitudinally
extending slot that allows the end portion of the respective stop to be
radially compressed to a smaller diameter.

2. The delivery device of claim 1, wherein the at least one
longitudinally extending slot in each stop end portion is configured to
allow a balloon-inflation fluid to flow radially through the respective
stop.

3. The delivery device of claim 2, wherein, when the prosthetic device is
mounted on the delivery device in the radially compressed state, the
proximal stop and the distal stop are configured to allow a
balloon-inflation fluid to flow from a proximal portion of the balloon,
through the at least one slot in the proximal stop, through an
intermediate portion of the balloon positioned within the prosthetic
device, through the at least one slot in the distal stop, and into a
distal portion of the balloon.

4. The delivery device of claim 1, wherein a proximal end of the balloon
is attached to the proximal stop and a distal end of the balloon is
attached to the distal stop.

5. The delivery device of claim 1, wherein the delivery device further
comprises an outer shaft having a lumen and an inner shaft extending
through the lumen of the outer shaft, wherein the proximal stop is
attached to a distal end of the outer shaft and/or attached to an outer
surface of the inner shaft, and wherein the distal stop is attached to an
outer surface of the inner shaft.

6. The delivery device of claim 5, wherein the proximal stop further
comprises: a proximal portion attached to the distal end of the outer
shaft and to a proximal end of the balloon; and an intermediate portion
between the proximal portion and the end portion, the intermediate
portion having an outer diameter that is less than an outer diameter of
the proximal portion and less than the diameter of the end portion.

7. The delivery device of claim 5, wherein the proximal stop is attached
to the distal end of the outer shaft and further comprises at least one
fluid passageway that allows an inflation fluid to flow through the at
least one passageway and into the balloon.

8. The delivery device of claim 5, wherein the distal stop further
comprises: a distal portion attached to a distal end of the balloon; and
an intermediate portion between the distal portion and the end portion,
the intermediate portion having an outer diameter that is less than an
outer diameter of the distal portion and less than the diameter of the
end portion.

9. The delivery device of claim 1, wherein the end portion of each stop
decreases in diameter in a direction extending away from the prosthetic
device.

10. The delivery device of claim 1, wherein the delivery device further
comprises a nosecone attached to a distal end of the distal stop.

11. The delivery device of claim 1, wherein at least one of the stop end
portions comprises at least three longitudinal slots that allow the stop
end portion to be radially compressed to a smaller diameter when the
prosthetic device is crimped onto the delivery device.

12. The delivery device of claim 1, in combination with a prosthetic
heart valve crimped onto the balloon between the proximal and distal
stops.

13. A method of implanting a prosthetic heart valve within the heart, the
method comprising: introducing a distal end portion of a delivery device
into the native aortic valve of the heart, a distal end portion of the
delivery device comprising an inflatable balloon, a proximal stop and a
distal stop positioned at least partially within the balloon, and a
radially expandable prosthetic heart valve mounted over the balloon and
between the proximal stop and the distal stop in a radially compressed
state; inflating the balloon to radially expand the prosthetic heart
valve within the native aortic valve, wherein the balloon is inflated
with an inflation fluid that flows radially through the proximal and
distal stops; deflating the balloon; and retracting the delivery device
from the heart.

14. The method of claim 13, wherein the proximal stop is positioned
adjacent to a proximal end of the prosthetic heart valve and the distal
stop is positioned adjacent to a distal end of the prosthetic heart
valve, such that the prosthetic device is longitudinally contained
between the proximal and distal stops during introduction of the delivery
heart valve into the heart.

15. The method of claim 13, wherein inflating the balloon comprises
causing the inflation fluid to flow: through a first passageway in the
proximal stop and into a proximal portion of the balloon; from the
proximal portion of the balloon, through a second passageway in the
proximal stop, and into an intermediate portion of the balloon within the
prosthetic device; and from the intermediate portion of the balloon,
through a passageway in the distal stop, and into a distal portion of the
balloon.

16. The method of claim 15, further comprising, prior to introducing the
delivery device into the heart, crimping the prosthetic heart valve to
the radially compressed state onto delivery device while simultaneously
radially compressing the proximal stop and the distal stop.

17. The method of claim 16, wherein the prosthetic heart valve has a
first outer diameter in the radially compressed state and the proximal
stop and distal stop are compressed from a second outer diameter to about
the first outer diameter during the crimping.

18. The method of claim 17, wherein, when compressive pressure is
released after the crimping, the proximal stop and distal stop
resiliently expand from about the first outer diameter to about the
second outer diameter.

19. The method of claim 13, wherein introducing the distal end portion of
a delivery device into the native aortic valve of the heart comprises
inserting the distal end portion of a delivery device through an incision
in a patient's chest to reach the heart.

20. A system for delivering a prosthetic device into a patient,
comprising: an introducer sheath configured to be inserted partially into
a patient; a loader configured to be inserted into a proximal end the
introducer sheath; and a delivery device configured to be passed through
the loader and the introducer sheath into the patient carrying a
prosthetic device to be implanted in the patient; wherein the loader
comprises a flush port for selectively introducing fluid into the loader
and a bleed port for selectively releasing fluid from within the loader,
and both the flush port and the bleed port are sealed with a resiliently
flexible annular sealing member.

21. The system of claim 20, wherein the sealing member comprises push tab
that extends radially through the bleed port, such that the bleed port is
configured to be selectively opened by depressing the push tab in the
radially inward direction.

Description:

CROSS REFERENCE TO RELATED APPLICATION

[0001] The present application claims the benefit of U.S. Provisional
Application No. 61/512,328, filed Jul. 27, 2011, which is incorporated
herein by reference.

[0003] Prosthetic cardiac valves have been used for many years to treat
cardiac valvular disorders. The native heart valves (such as the aortic,
pulmonary and mitral valves) serve critical functions in assuring the
forward flow of an adequate supply of blood through the cardiovascular
system. These heart valves can be rendered less effective by congenital,
inflammatory or infectious conditions. Such damage to the valves can
result in serious cardiovascular compromise or death. For many years the
definitive treatment for such disorders was the surgical repair or
replacement of the valve during open heart surgery, but such surgeries
are prone to many complications. More recently a transvascular technique
has been developed for introducing and implanting a prosthetic heart
valve using a flexible catheter in a manner that is less invasive than
open heart surgery.

[0004] In this technique, a prosthetic valve is mounted in a crimped state
on the end portion of a flexible catheter and advanced through a blood
vessel of the patient until the prosthetic valve reaches the implantation
site. The prosthetic valve at the catheter tip is then expanded to its
functional size at the site of the defective native valve such as by
inflating a balloon on which the prosthetic valve is mounted.
Alternatively, the prosthetic valve can have a resilient, self-expanding
stent or frame that expands the prosthetic valve to its functional size
when it is advanced from a delivery sheath at the distal end of the
catheter.

[0005] A prosthetic valve that has a relatively large profile or diameter
in the compressed state can inhibit the physician's ability to advance
the prosthetic valve through the femoral artery or vein. More
particularly, a smaller profile allows for treatment of a wider
population of patients, with enhanced safety. Thus, a need exists for
delivery devices that can minimize the overall crimp profile of the
prosthetic valve for the delivery of the prosthetic valve through the
patient's vasculature.

[0006] Relatively long delivery devices, such as used for transfemoral
delivery of a prosthetic valve, can inhibit the physician's ability to
position the prosthetic valve precisely at the desired implantation site
because the forces applied to the handle at one end of the delivery
device can cause unwanted movement of the prosthetic valve at the
opposite end of the delivery device. Thus, a need exists for delivery
devices that allow a physician to accurately control the positioning of
the prosthetic valve at the desired implantation location.

[0007] When introducing a delivery device into the body, an introducer
sheath typically is inserted first and then the delivery device is
inserted through the introducer sheath and into the body. If the
prosthetic valve is mounted on a balloon catheter, the prosthetic valve
can contact the inner surface of the introducer sheath and may become
dislodged from its preferred location on the balloon catheter, depending
on the size of the crimped valve. Thus, a need exists for delivery
devices that can better retain the crimped valve at its desired location
on the balloon catheter as it is advanced through an introducer sheath.

SUMMARY

[0008] Described herein are systems and methods for delivering prosthetic
devices, such as prosthetic heart valves, through the body and into the
heart for implantation therein. The prosthetic devices delivered with the
delivery systems disclosed herein are, for example, radially expandable
from a radially compressed state mounted on the delivery system to a
radially expanded state for implantation using an inflatable balloon (or
equivalent expansion device) of the delivery system. Exemplary delivery
routes through the body and into the heart include transfemoral routes,
transapical routes, and transaortic routes, among others. Although the
devices and methods disclosed herein are particular suited for implanting
prosthetic heart valves (e.g., a prosthetic aortic valve or prosthetic
mitral valve), the disclosed devices and methods can be adapted for
implanting other types of prosthetic valves within the body (e.g.,
prosthetic venous valves) or other types of expandable prosthetic devices
adapted to be implanted in various body lumens.

[0009] In some embodiments, a delivery apparatus for implanting a
prosthetic, transcatheter heart valve via a patient's vasculature
includes an adjustment device for adjusting the position of a balloon
relative to a crimped prosthetic valve (and/or vice versa). A balloon
catheter can extend coaxially with a guide (or flex) catheter, and a
balloon member at the distal end of the balloon catheter can be
positioned proximal or distal to a crimped prosthetic valve. The balloon
member and the crimped prosthetic valve can enter the vasculature of a
patient through an introducer sheath and, once the balloon member and the
crimped prosthetic valve reach a suitable location in the body, the
relative position of the prosthetic valve and balloon member can be
adjusted so that the balloon member is positioned within the frame of the
prosthetic valve so that the prosthetic valve eventually can be expanded
at the treatment site. Once the crimped prosthetic valve is positioned on
the balloon, the prosthetic valve is advanced to the vicinity of the
deployment location (i.e., the native aortic valve) and the adjustment
device can further be used to accurately adjust or "fine tune" the
position of the prosthetic valve relative to the desired deployment
location.

[0010] An exemplary method of implanting a radially compressible and
expandable prosthetic device (e.g., a prosthetic heart valve) in the
heart comprises: (a) introducing a delivery device into the body of a
patient, the delivery device comprising a handle portion, an elongated
shaft extending from the handle portion, the shaft having a distal end
portion mounting an inflatable balloon and a prosthetic heart valve in a
radially compressed state; (b) advancing the distal end portion of the
delivery device toward the native heart valve until the prosthetic valve
is within or adjacent the annulus of the native heart valve; (c)
positioning the prosthetic heart valve at a desired implantation position
within the annulus of the native by rotating an adjustment device coupled
to the handle portion and the shaft to cause the shaft and the prosthetic
valve to move distally and/or proximally relative to the handle portion
until the prosthetic heart valve is at the desired implantation position;
and (d) after the prosthetic heart valve has been moved to the desired
implantation position, inflating the balloon to cause the prosthetic
heart valve to radially expand and engage the annulus of the native heart
valve.

[0011] An exemplary delivery apparatus for implantation of a prosthetic
device (e.g., a prosthetic heart valve) in the heart comprises an
elongated shaft comprising a proximal end portion and a distal end
portion, an inflatable balloon, and a valve mounting member. The balloon
is mounted on the distal end portion of the shaft. The valve mounting
member is disposed on the distal end portion of the shaft within the
balloon and is configured to facilitate frictional engagement between the
prosthetic heart valve and the balloon when the prosthetic heart valve is
mounted in a radially compressed state on the balloon and surrounding the
mounting member. The mounting member comprises at least one
longitudinally extending fluid passageway though which an inflation fluid
in the balloon can flow.

[0012] In some embodiments, the at least one fluid passageway has first
and second openings adjacent first and second ends of the prosthetic
heart valve, respectively. When the prosthetic valve is mounted on the
balloon in a crimped state, the inflation fluid in the balloon can flow
from a first region of the balloon proximal to the first end of the
prosthetic valve, inwardly through the first opening, through the fluid
passageway, outwardly through the second opening and into a second region
of the balloon distal to the second end of the prosthetic valve.

[0013] Another exemplary delivery apparatus for implantation of a
prosthetic device (e.g., a prosthetic heart valve) in the heart comprises
a handle portion and an elongated shaft extending from the handle
portion. The shaft comprises a proximal end portion coupled to the handle
portion and a distal end portion configured to mount a prosthetic heart
valve in a radially compressed state. The apparatus also comprises a
sliding member disposed on the proximal end portion of the shaft. The
handle portion comprising a rotatable member that is operatively coupled
to the sliding member so as to cause translational movement of the
sliding member upon rotation of the rotatable member. A shaft engagement
member is disposed on the shaft and couples the shaft to the sliding
member. The shaft engagement member is configured to be manipulated
between a first state and a second state. In the first state, the shaft
can move freely in the longitudinal direction relative to the sliding
member and the rotatable member. In the second state, the shaft
engagement member frictionally engages the shaft and prevents rotational
and longitudinal movement of the shaft relative to the sliding member
such that rotation of the rotatable member causes corresponding
longitudinal movement of the sliding member and the shaft. When a
prosthetic device is mounted on the distal end of the shaft and the shaft
engagement member is manipulated to engage the shaft, the rotatable
member can be used to adjust the location of the prosthetic device
relative to its desired implantation location within the heart.

[0014] In some embodiments, the shaft engagement member comprises a collet
disposed on the shaft. The collet can have flexible fingers that can be
forced to frictionally engage and retain the shaft relative to the
sliding member so that the rotatable member can be used to adjust the
position of the prosthetic device mounted on the distal end portion of
the shaft.

[0015] Another exemplary delivery device for implantation of a prosthetic
device (e.g., a prosthetic heart valve) within the heart, such as via a
transapical or transaortic route, comprises an inflatable balloon, a
proximal stop, and a distal stop. The stops are configured to limit
longitudinal movement of the prosthetic device relative to the balloon
while the prosthetic device is mounted over the balloon in the radially
compressed state between the proximal stop and the distal stop. The
proximal stop and the distal stop each comprise an end portion positioned
within the balloon and configured to be positioned adjacent the
prosthetic device when the prosthetic device is radially compressed
between the proximal and distal stops. Each of the stop end portions
comprises at least one longitudinally extending slot that allows the
respective stop end portion to be radially compressed to a smaller
diameter. The at least one longitudinally extending slot in each stop end
portion can also be configured to allow a balloon-inflation fluid to flow
radially through the respective stop and into the region of the balloon
extending through the prosthetic valve.

[0016] In some embodiments, when a prosthetic device is mounted on the
delivery device in the radially compressed state, the proximal stop and
the distal stop are configured to allow a balloon-inflation fluid to flow
from a proximal portion of the balloon, through the at least one slot in
the proximal stop, through an intermediate portion of the balloon
positioned within the prosthetic device, through the at least one slot in
the distal stop, and into a distal portion of the balloon.

[0017] In some embodiments, a proximal end of the balloon is attached to
the proximal stop and a distal end of the balloon is attached to the
distal stop.

[0018] In some embodiments, the delivery device further comprises an outer
shaft having a lumen and an inner shaft extending through the lumen of
the outer shaft, with the proximal stop attached to a distal end of the
outer shaft and positioned around the inner shaft and the distal stop
attached to an outer surface of the inner shaft.

[0019] In some embodiments, the proximal stop further comprises a proximal
portion attached to the distal end of the outer shaft and to a proximal
end of the balloon, and an intermediate portion extending between the
proximal portion and the end portion, the intermediate portion having an
outer diameter that is less than an outer diameter of the proximal
portion and less than the diameter of the end portion.

[0020] In some embodiments, the proximal stop is attached to the distal
end of the outer shaft and further comprises at least one fluid
passageway that allows an inflation fluid to flow through the at least
one passageway and into the balloon.

[0021] In some embodiments, the distal stop further comprises a distal
portion attached to a distal end of the balloon and an intermediate
portion extending between the distal portion and the end portion, the
intermediate portion having an outer diameter that is less than an outer
diameter of the distal portion and less than the diameter of the end
portion.

[0022] In some embodiments, the end portion of each stop decreases in
diameter in a direction extending away from the prosthetic device.

[0023] In some embodiments, the delivery device further comprises a
nosecone attached to a distal end of the distal stop.

[0024] In some embodiments, at least one of the stop end portions
comprises at least three longitudinal slots that allow the stop end
portion to be radially compressed to a smaller diameter when the
prosthetic device is crimped onto the delivery device.

[0025] An exemplary method of implanting a prosthetic heart valve within
the heart comprises: (a) introducing a distal end portion of a delivery
device into the native aortic valve of the heart, a distal end portion of
the delivery device comprising an inflatable balloon, a proximal stop and
a distal stop positioned at least partially within the balloon, and a
radially expandable prosthetic heart valve mounted over the balloon and
between the proximal stop and the distal stop in a radially compressed
state; (b) inflating the balloon to radially expand the prosthetic heart
valve within the native aortic valve, wherein the balloon is inflated
with an inflation fluid that flows radially through the proximal and
distal stops; (c) deflating the balloon; and (d) retracting the delivery
device from the heart.

[0026] In some embodiments, the proximal stop is positioned adjacent to a
proximal end of the prosthetic heart valve and the distal stop is
positioned adjacent to a distal end of the prosthetic heart valve, such
that the prosthetic device is longitudinally contained between the
proximal and distal stops during introduction of the prosthetic heart
valve through an introducer sheath into the body.

[0027] In some embodiments, inflating the balloon comprises causing the
inflation fluid to flow: (i) through a first passageway in the proximal
stop and into a proximal portion of the balloon; (ii) from the proximal
portion of the balloon, through a second passageway in the proximal stop,
and into an intermediate portion of the balloon within the prosthetic
device; and (iii) from the intermediate portion of the balloon, through a
passageway in the distal stop, and into a distal portion of the balloon.

[0028] In some embodiments, prior to introducing the delivery device into
the heart, the prosthetic heart valve is crimped to the radially
compressed state onto delivery device while the proximal stop and the
distal stop are simultaneously radially compressed. The prosthetic heart
valve can have a first outer diameter in the radially compressed state
and the proximal stop and distal stop can be compressed from a second
outer diameter to about the first outer diameter during the crimping.
When compressive pressure is released after the crimping, the proximal
stop and distal stop can be configured to resiliently expand from about
the first outer diameter to about the second outer diameter.

[0029] An exemplary system for delivering a prosthetic device into a
patient comprises an introducer sheath configured to be inserted
partially into a patient, a loader configured to be inserted into a
proximal end the introducer sheath, and a delivery device configured to
be passed through the loader and the introducer sheath into the patient
carrying a prosthetic device to be implanted in the patient. The loader
comprises a flush port for selectively introducing fluid into the loader
and a bleed port for selectively releasing fluid from within the loader,
and both the flush port and the bleed port are sealed with the same
resiliently flexible annular sealing member. The sealing member can
comprise a push tab that extends radially through the bleed port, such
that the bleed port is configured to be selectively opened by depressing
the push tab in the radially inward direction.

[0030] The foregoing and other objects, features, and advantages of the
invention will become more apparent from the following detailed
description, which proceeds with reference to the accompanying figures.

BRIEF DESCRIPTION OF THE DRAWINGS

[0031]FIG. 1 is a side view of a delivery apparatus for implanting a
prosthetic heart valve, according to one embodiment.

[0032]FIG. 2A is a cross-sectional view of the handle of the delivery
apparatus of FIG. 1.

[0033]FIG. 2B is another cross-sectional view of the handle of the
delivery apparatus of FIG. 1.

[0034]FIG. 3 is side view of a section of the handle and a section of the
distal end portion of the delivery apparatus of FIG. 1.

[0035]FIG. 4 is a side view of the distal end portion of the delivery
apparatus of FIG. 1.

[0036]FIG. 5 is a side view of the distal end portion of the delivery
apparatus of FIG. 1 showing the balloon in an inflated state.

[0037]FIG. 6 is an enlarged perspective view of a collet used in the
handle of the delivery apparatus of FIG. 1.

[0039]FIG. 8 is an enlarged side view of a mounting member for a
prosthetic heart valve.

[0040] FIGS. 9-11 are enlarged, cross-sectional views of the distal end
portion of the delivery apparatus of FIG. 1, showing the inflation of a
balloon for deployment of a prosthetic heart valve on the balloon.

[0041]FIG. 12 is a perspective view of an alternative embodiment of a
mounting member for a prosthetic heart valve.

[0042] FIG. 13 is a side view of the mounting member of FIG. 12 shown
partially in section.

[0044] FIGS. 15-17 are enlarged, cross-sectional views of the distal end
portion of a delivery apparatus containing the mounting member of FIG.
12, and showing the inflation of a balloon for deployment of a prosthetic
heart valve on the balloon.

[0045] FIG. 18 is an exploded perspective view of the handle of a delivery
apparatus, according to another embodiment.

[0046]FIG. 19 is an enlarged perspective view of the collet, pusher
element, spring, ring, and washer of the handle shown in FIG. 18.

[0047]FIG. 20 is a cross-sectional view of the handle of the delivery
apparatus of FIG. 18.

[0048]FIG. 21 is another cross-sectional view of the handle of the
delivery apparatus of FIG. 18.

[0049] FIG. 22 is a perspective view of the inner shaft, or slider, of the
handle shown in FIG. 18.

[0050] FIG. 23 is an enlarged side view of the inner nut of the handle
shown in FIG. 18.

[0051]FIG. 24 is an enlarged cross-sectional view of the inner nut shown
in FIG. 23.

[0052] FIGS. 25-27 are enlarged top, perspective and end views,
respectively, of the rotatable knob of the handle shown in FIG. 18.

[0053] FIG. 28 is an enlarged perspective view of the indicator ring of
the handle shown in FIG. 18.

[0054] FIGS. 29-31 are cross-sectional views of the distal end portion of
a delivery apparatus for a prosthetic heart valve, according to another
embodiment, having two inflatable balloons for deploying a prosthetic
valve.

[0055]FIG. 32 is a side view of a delivery apparatus for a prosthetic
heart valve, an introducer, and a loader device, according to another
embodiment.

[0056]FIG. 33 is an enlarged, cross-sectional view of the distal end
portion of the delivery apparatus of FIG. 32.

[0059]FIG. 36 is a perspective view of the handle of the delivery
apparatus shown in FIG. 32.

[0060]FIG. 37 is a partially exploded, perspective view of the handle of
FIG. 36.

[0061]FIG. 38 is a perspective view of the handle of FIG. 36, shown with
a portion of the outer housing cut away for purposes of illustration.

[0062]FIG. 39 is an exploded, perspective view of the handle of FIG. 36.

[0063]FIG. 40 is a perspective view of another embodiment of a handle
that can be used in the delivery apparatus of FIG. 32.

[0064]FIG. 41 is a perspective of the handle of FIG. 40, with a portion
of the outer housing and some internal components removed for purposes of
illustration.

[0065]FIG. 42 is an exploded, perspective view of the handle of FIG. 40.

[0066]FIG. 43 is a perspective view of another embodiment of a handle
that can be used in the delivery apparatus of FIG. 32.

[0067]FIG. 44 is a perspective of the handle of FIG. 43, with a portion
of the outer housing and some internal components removed for purposes of
illustration.

[0068]FIG. 45 is an exploded, perspective view of the handle of FIG. 43.

[0069]FIG. 46 is a perspective view of a delivery apparatus for a
prosthetic heart valve, according to another embodiment.

[0070]FIG. 47 is an enlarged, cross-sectional view of the distal end
portion of the delivery apparatus of FIG. 46.

[0071]FIG. 47A is an enlarged, cross-sectional view of the distal end
portion of the delivery apparatus of FIG. 46 showing a prosthetic heart
valve mounted in a crimped state on the balloon of the delivery
apparatus.

[0072] FIG. 48 is a perspective view of the handle of the delivery
apparatus of FIG. 46, with a portion of the outer housing removed for
purposes of illustration.

[0073]FIG. 49 is a perspective view of an introducer, according to
another embodiment.

[0074]FIG. 50 is an enlarged, cross-sectional view of the proximal
housing portion of the introducer shown in FIG. 49.

[0075]FIG. 51 is a perspective view of a loader, according to another
embodiment.

[0076]FIG. 52 is a cross-sectional view of the loader shown in FIG. 51.

[0077]FIG. 53 is a perspective view of the loader of FIG. 51 shown
inserted into the introducer of FIG. 49.

[0078]FIG. 54 is a perspective view of the button valve of the loader
shown in FIG. 51.

[0079]FIG. 55 is a top plan view of the button valve shown in FIG. 51.

[0080] FIG. 56 is a perspective view of a prosthetic heart valve,
according to one embodiment.

[0081]FIG. 57 is a side elevation view of the prosthetic heart valve of
FIG. 56.

DETAILED DESCRIPTION

[0082] In particular embodiments, a delivery apparatus for implanting a
prosthetic, transcatheter heart valve via a patient's vasculature
includes an adjustment device for adjusting the position of a balloon
relative to a crimped prosthetic valve (and/or vice versa). A balloon
catheter can extend coaxially with a guide (or flex) catheter, and a
balloon member at the distal end of the balloon catheter can be
positioned proximal or distal to a crimped prosthetic valve. As described
below in more detail, the balloon member and the crimped prosthetic valve
can enter the vasculature of a patient through an introducer sheath and,
once the balloon member and the crimped prosthetic valve reach a suitable
location in the body, the relative position of the prosthetic valve and
balloon member can be adjusted so that the balloon member is positioned
within the frame of the prosthetic valve so that the prosthetic valve
eventually can be expanded at the treatment site. Once the crimped
prosthetic valve is positioned on the balloon, the prosthetic valve is
advanced to the vicinity of the deployment location (i.e., the native
aortic valve) and the adjustment device can further be used to accurately
adjust or "fine tune" the position of the prosthetic valve relative to
the desired deployment location.

[0083]FIG. 1 shows a delivery apparatus 10 adapted to deliver a
prosthetic heart valve 12 (shown schematically in FIGS. 9-11) (e.g., a
prosthetic aortic valve) to a heart, according to one embodiment. The
apparatus 10 generally includes a steerable guide catheter 14 (FIG. 3),
and a balloon catheter 16 extending through the guide catheter 14. The
guide catheter can also be referred to as a flex catheter or a main
catheter. The use of the term main catheter should be understood,
however, to include flex or guide catheters, as well as other catheters
that do not have the ability to flex or guide through a patient's
vasculature.

[0084] The guide catheter 14 and the balloon catheter 16 in the
illustrated embodiment are adapted to slide longitudinally relative to
each other to facilitate delivery and positioning of prosthetic valve 12
at an implantation site in a patient's body, as described in detail
below.

[0085] The guide catheter 14 includes a handle portion 20 and an elongated
guide tube, or shaft, 22 extending from handle portion 20 (FIG. 3). FIG.
1 shows the delivery apparatus without the guide catheter shaft 22 for
purposes of illustration. FIG. 3 shows the guide catheter shaft 22
extending from the handle portion 20 over the balloon catheter. The
balloon catheter 16 includes a proximal portion 24 (FIG. 1) adjacent
handle portion 20 and an elongated shaft 26 that extends from the
proximal portion 24 and through handle portion 20 and guide tube 22. The
handle portion 20 can include a side arm 27 having an internal passage
which fluidly communicates with a lumen defined by the handle portion 20.

[0086] An inflatable balloon 28 is mounted at the distal end of balloon
catheter 16. As shown in FIG. 4, the delivery apparatus 10 is configured
to mount the prosthetic valve 12 in a crimped state proximal to the
balloon 28 for insertion of the delivery apparatus and prosthetic valve
into a patient's vasculature, which is described in detail in U.S.
Publication No. 2009/0281619 (U.S. application Ser. No. 12/247,846, filed
Oct. 8, 2008), which is incorporated herein by reference. Because
prosthetic valve 12 is crimped at a location different from the location
of balloon 28 (e.g., in this case prosthetic valve 12 desirably is
crimped proximal to balloon 28), prosthetic valve 12 can be crimped to a
lower profile than would be possible if prosthetic valve 12 was crimped
on top of balloon 28. This lower profile permits the surgeon to more
easily navigate the delivery apparatus (including crimped valve 12)
through a patient's vasculature to the treatment location. The lower
profile of the crimped prosthetic valve is particularly helpful when
navigating through portions of the patient's vasculature which are
particularly narrow, such as the iliac artery. The lower profile also
allows for treatment of a wider population of patients, with enhanced
safety.

[0087] A nose piece 32 (FIG. 4) can be mounted at the distal end of the
delivery apparatus 10 to facilitate advancement of the delivery apparatus
10 through the patient's vasculature to the implantation site. In some
instances, it may be useful to have nose piece 32 connected to a separate
elongated shaft so that nose piece 32 can move independently of other
elements of delivery apparatus 10. Nose piece 32 can be formed of a
variety of materials, including various plastic materials.

[0088] As can be seen in FIG. 5, the balloon catheter 16 in the
illustrated configuration further includes an inner shaft 34 (FIG. 2A)
that extends from proximal portion 24 and coaxially through the outer
balloon catheter shaft 26 and the balloon 28. The balloon 28 can be
supported on a distal end portion of inner shaft 34 that extends
outwardly from the outer shaft 26 with a proximal end portion 36 of the
balloon secured to the distal end of outer shaft 26 (e.g., with a
suitable adhesive) (FIG. 5). The outer diameter of inner shaft 34 is
sized such that an annular space is defined between the inner and outer
shafts along the entire length of the outer shaft. The proximal portion
24 of the balloon catheter can be formed with a fluid passageway (not
shown) that is fluidly connectable to a fluid source (e.g., saline) for
inflating the balloon. The fluid passageway is in fluid communication
with the annular space between inner shaft 34 and outer shaft 26 such
that fluid from the fluid source can flow through fluid passageway,
through the space between the shafts, and into balloon 28 to inflate the
same and deploy prosthetic valve 12.

[0089] The proximal portion 24 also defines an inner lumen that is in
communication with a lumen 38 of the inner shaft 34 that is sized to
receive guide wire (not shown) that can extend coaxially through the
inner shaft 34 and the nose cone 32.

[0090] The inner shaft 34 and outer shaft 26 of the balloon catheter can
be formed from any of various suitable materials, such as nylon, braided
stainless steel wires, or a polyether block amide (commercially available
as Pebax®). The shafts 26, 34 can have longitudinal sections formed
from different materials in order to vary the flexibility of the shafts
along their lengths. The inner shaft 34 can have an inner liner or layer
formed of Teflon® to minimize sliding friction with a guide wire.

[0091] The distal end portion of the guide catheter shaft 22 comprises a
steerable section 68 (FIG. 3), the curvature of which can be adjusted by
the operator to assist in guiding the apparatus through the patient's
vasculature, and in particular, the aortic arch. The handle 20 in the
illustrated embodiment comprises a distal handle portion 46 and a
proximal handle portion 48. The distal handle portion 46 functions as a
mechanism for adjusting the curvature of the distal end portion of the
guide catheter shaft 22 and as a flex indicating device that allows a
user to measure the relative amount of flex of the distal end of the
guide catheter shaft 22. In addition, the flex indicating device provides
a visual and tactile response at the handle the device, which provides a
surgeon with an immediate and direct way to determine the amount of flex
of the distal end of the catheter.

[0092] The distal handle portion 46 can be operatively connected to the
steerable section 68 and functions as an adjustment mechanism to permit
operator adjustment of the curvature of the steerable section via manual
adjustment of the handle portion. Explaining further, the handle portion
46 comprises a flex activating member 50, an indicator pin 52, and a
cylindrical main body, or housing 54. As shown in FIGS. 2A and 2B, the
flex activating member 50 comprises an adjustment knob 56 and a shaft 58
extending proximally from the knob into the housing 54. A proximal end
portion of the guide catheter shaft 22 extends into and is fixed within
the central lumen of the housing 54. An inner sleeve 70 surrounds a
portion of the guide catheter shaft 22 inside the housing 54. A threaded
slide nut 72 is disposed on and is slidable relative to the sleeve 70.
The slide nut 72 is formed with external threads that mate with internal
threads 60 of the shaft 58.

[0093] The slide nut 72 can be formed with two slots formed on the inner
surface of the nut and extending the length thereof. The sleeve 70 can be
formed with longitudinally extending slots that are aligned with the
slots of the slide nut 72 when the slide nut is placed on the sleeve.
Disposed in each slot is a respective elongated nut guide, which can be
in the form of an elongated rod or pin 76. The nut guides 76 extend
radially into respective slots in the slide nut 72 to prevent rotation of
the slide nut 72 relative to the sleeve 70. By virtue of this
arrangement, rotation of the adjustment knob 56 (either clockwise or
counterclockwise) causes the slide nut 72 to move longitudinally relative
to the sleeve 70 in the directions indicated by double-headed arrow 74.

[0094] One or more pull wires 78 (FIG. 2A) couple the adjustment knob 56
to the steerable section 68 to adjust the curvature of the steerable
section upon rotation of the adjustment knob. For example, the proximal
end portion of the pull wire 78 can extend into and can be secured to a
retaining pin, such as by crimping the pin around the proximal end of the
pull wire, which pin is disposed in a slot in the slide nut 72. The pull
wire extends from the pin, through the slot in the slide nut, a slot in
the sleeve 70, and into and through a pull wire lumen in the shaft 22.
The distal end portion of the pull wire is secured to the distal end
portion of the steerable section 68.

[0095] The pin, which retains the proximal end of the pull wire 78, is
captured in the slot in the slide nut 72. Hence, when the adjustment knob
56 is rotated to move the slide nut 72 in the proximal direction, the
pull wire also is moved in the proximal direction. The pull wire pulls
the distal end of the steerable section 68 back toward the handle
portion, thereby bending the steerable section and reducing its radius of
curvature. The friction between the adjustment knob 56 and the slide nut
72 is sufficient to hold the pull wire taut, thus preserving the shape of
the bend in the steerable section if the operator releases the adjustment
knob 56. When the adjustment knob 56 is rotated in the opposite direction
to move the slide nut 72 in the distal direction, tension in the pull
wire is released. The resiliency of the steerable section 68 causes the
steerable to return its normal, non-deflected shape as tension on the
pull wire is decreased. Because the pull wire is not fixedly secured to
the slide nut 72 (the pin can move within the slot in the nut), movement
of the slide nut in the distal direction does not push on the end of the
pull wire, causing it to buckle. Instead, the pin is allowed to float
within the slot of the slide nut 72 when the knob 56 is adjusted to
reduce tension in the pull wire, preventing buckling of the pull wire.

[0096] In particular embodiments, the steerable section 68 in its
non-deflected shape is slightly curved and in its fully curved position,
the steerable section generally conforms to the shape of the aortic arch.
In other embodiments, the steerable section can be substantially straight
in its non-deflected position.

[0097] The distal handle portion 46 can have other configurations that are
adapted to adjust the curvature of the steerable section 68. One such
alternative handle configuration is shown in co-pending U.S. patent
application Ser. No. 11/152,288 (published under Publication No.
US2007/0005131), which is incorporated herein by reference in its
entirety. Additional details relating to the steerable section and handle
configuration discussed above can be found in U.S. patent application
Ser. No. 11/852977 (published as U.S. Publication No. US2008/0065011),
which is incorporated herein by reference in its entirety.

[0098] The shaft 58 also includes an externally threaded surface portion
62. As shown in FIG. 2B, a base portion 64 of the indicator pin 52 mates
with the externally threaded surface portion 62 of the shaft 58. The
shaft 58 extends into the main body 54 and the indicator pin 52 is
trapped between the externally threaded surface portion 62 and the main
body 54, with a portion of the indicator pin 52 extending into a
longitudinal slot 66 of the handle. As the knob 56 rotated to increase
the curvature of the distal end of the guide catheter shaft 22, the
indicator pin 52 tracks the external threaded portion 62 of the flex
activating member and moves in the proximal direction inside of the slot
66. The greater the amount of rotation of the knob 56, the further
indicator pin 52 moves towards the proximal end of the proximal handle
portion 46. Conversely, rotating the knob 56 in the opposite direction
decreases the curvature of the distal end of the guide catheter shaft 22
(i.e., straightens the guide catheter shaft) and causes corresponding
movement of the indicator pin 52 toward the distal end of the distal
handle portion 46.

[0099] The outer surface of the main body 54 of the distal handle portion
46 can include visual indicia adjacent the slot 66 that indicate the
amount of flex of the distal end of the guide catheter shaft 22, based on
the position of the indicator pin 52 relative to the visual indicia. Such
indicia can identify the amount of flex in any of a variety of manners.
For example, the outer surface of the main body 54 can include a series
of numbers (e.g., 0 to 10) adjacent the slot that indicate the amount of
curvature of the guide catheter shaft 22 based on the position of the
indicator pin 52 relative to the number scale.

[0100] As described above, when the delivery apparatus is introduced into
the vasculature of the patient, a crimped prosthetic valve 12 is
positioned proximal to the balloon 28 (FIG. 4). Prior to expansion of the
balloon 28 and deployment of prosthetic valve 12 at the treatment site,
the prosthetic valve 12 is moved relative to the balloon (or vice versa)
to position the crimped prosthetic valve on the balloon for deploying
(expanding) the prosthetic valve. As discussed below, the proximal handle
portion 48 serves as an adjustment device that can be used to move the
balloon 28 proximally into position within the frame of prosthetic valve
12, and further to accurately position the balloon and the prosthetic
valve at the desired deployment location.

[0101] As shown in FIGS. 2A and 2B, the proximal handle portion 48
comprises an outer housing 80 and an adjustment mechanism 82. The
adjustment mechanism 82, which is configured to adjust the axial position
of the balloon catheter shaft 26 relative to the guide catheter shaft 22,
comprises an adjustment knob 84 and a shaft 86 extending distally into
the housing 80. Mounted within the housing 80 on the balloon catheter
shaft 26 is an inner support 88, which in turn mounts an inner shaft 90
(also referred to as a slider or sliding mechanism) (also shown in FIG.
22). The inner shaft 90 has a distal end portion 92 formed with external
threads that mate with internal threads 94 that extend along the inner
surface of the adjustment mechanism 82. The inner shaft 90 further
includes a proximal end portion 96 that mounts a securement mechanism 98,
which is configured to retain the position of the balloon catheter shaft
26 relative to the proximal handle portion 48 for use of the adjustment
mechanism 82, as further described below. The inner shaft 90 can be
coupled to the inner support 88 such that rotation of shaft 86 causes the
inner shaft 90 to move axially within the handle. For example, the inner
support 88 can have an axially extending rod or rail that extends into
slot formed in the inner surface of the inner shaft 90. The rod or rail
prevents rotation of the inner shaft 90 but allows it to move axially
upon rotation of the shaft 86.

[0102] The securement mechanism 98 includes internal threads that mate
with external threads of the proximal end portion 96 of the inner shaft.
Mounted within the proximal end portion 96 on the balloon catheter shaft
26 is a pusher element 100 and a shaft engagement member in the form of a
collet 102. The collet 102 is configured to be manipulated by the
securement mechanism between a first state in which collet allows the
balloon catheter shaft to be moved freely in the longitudinal and
rotational directions and a second state in which the collet frictionally
engages the balloon catheter shaft and prevents rotational and
longitudinal movement of the balloon catheter shaft relative to the inner
shaft 90, as further described below.

[0103] As best shown in FIGS. 6 and 7, the collet 102 comprises a distal
end portion 104, an enlarged proximal end portion 106, and a lumen 108
that receives the balloon catheter shaft 26. A plurality of axially
extending, circumferentially spaced slots 110 extend from the proximal
end of the collet to a location on the distal end portion 104, thereby
forming a plurality of flexible fingers 112. The proximal end portion can
be formed with a tapered end surface 114 that engages a corresponding
tapered end surface of the pusher element 100 (FIG. 2A).

[0104] As noted above, the securement mechanism 98 is operable to restrain
movement of the balloon catheter shaft 26 (in the axial and rotational
directions) relative to the proximal handle portion 48. Explaining
further, the securement mechanism 98 is movable between a proximal
position (shown in FIGS. 2A and 2B) and a distal position closer to the
adjacent end of the knob 84. In the proximal position, the collet 102
applies little, if any, force against the balloon catheter shaft 26,
which can slide freely relative to the collet 102, the entire handle 20,
and the guide catheter shaft 22. When the securement mechanism 98 is
rotated so as to move to its distal position closer to knob 84, the
securement mechanism urges pusher element 100 against the proximal end of
the collet 102. The tapered surface of the pusher element pushes against
the corresponding tapered surface 114 of the collet, forcing fingers 112
radially inward against the outer surface of the balloon catheter shaft
26. The holding force of the collet 102 against the balloon catheter
shaft locks the balloon catheter shaft relative to the inner shaft 90. In
the locked position, rotation of the adjustment knob 84 causes the inner
shaft 90 and the balloon catheter shaft 26 to move axially relative to
the guide catheter shaft 22 (either in the proximal or distal direction,
depending on the direction the knob 84 is rotated).

[0105] The adjustment knob 84 can be utilized to position the prosthetic
valve 12 on the balloon 28 and/or once the prosthetic valve 12 is on the
balloon, to position the prosthetic valve and the balloon at the desired
deployment site within the native valve annulus. One specific method for
implanting the prosthetic valve 12 in the native aortic valve is as
follows. The prosthetic valve 12 initially can be crimped on a mounting
region 120 (FIGS. 4 and 5) of the balloon catheter shaft 26 immediately
adjacent the proximal end of the balloon 28 or slightly overlapping the
proximal end of the balloon. The proximal end of the prosthetic valve can
abut the distal end 122 of the guide catheter shaft 22 (FIG. 4), which
keeps the prosthetic valve in place on the balloon catheter shaft as the
delivery apparatus and prosthetic valve are inserted through an
introducer sheath. The prosthetic valve 12 can be delivered in a
transfemoral procedure by first inserting an introducer sheath into the
femoral artery and pushing the delivery apparatus through the introducer
sheath into the patient's vasculature.

[0106] After the prosthetic valve 12 is advanced through the narrowest
portions of the patient's vasculature (e.g., the iliac artery), the
prosthetic valve 12 can be moved onto the balloon 28. For example, a
convenient location for moving the prosthetic valve onto the balloon is
the descending aorta. The prosthetic valve can be moved onto the balloon,
for example, by holding the handle portion 46 steady (which retains the
guide catheter shaft 22 in place), and moving the balloon catheter shaft
26 in the proximal direction relative to the guide catheter shaft 22. As
the balloon catheter shaft is moved in the proximal direction, the distal
end 122 of the guide catheter shaft pushes against the prosthetic valve,
allowing the balloon 28 to be moved proximally through the prosthetic
valve in order to center the prosthetic valve on the balloon, as depicted
in FIG. 9. The balloon catheter shaft can include one or more radiopaque
markers to assist the user in positioning the prosthetic valve at the
desired location on the balloon. The balloon catheter shaft 26 can be
moved in the proximal direction by simply sliding/pulling the balloon
catheter shaft in the proximal direction if the securement mechanism 98
is not engaged to retain the shaft 26. For more precise control of the
shaft 26, the securement mechanism 98 can be engaged to retain the shaft
26, in which case the adjustment knob 84 is rotated to effect movement of
the shaft 26 and the balloon 28.

[0107] As shown in FIG. 5, the delivery apparatus can further include a
mounting member 124 secured to the outer surface of the shaft 34 within
the balloon 28. The mounting member helps retain the prosthetic valve in
place on the balloon by facilitating the frictional engagement between
the prosthetic valve and the outer surface of the balloon. The mounting
member 124 helps retain the prosthetic valve in place for final
positioning of the prosthetic valve at the deployment location,
especially when crossing the native leaflets, which typically are
calcified and provide resistance against movement of the prosthetic
valve. The nose cone 32 can include a proximal portion 126 inside the
balloon to assist in positioning the prosthetic valve. The proximal
portion 126 desirably comprises a tapered member that has a maximum
diameter at its proximal end adjacent the distal end of the prosthetic
valve (FIG. 9) and tapers in a direction toward the distal end of the
nosecone 32. The tapered member 126 serves as a transition section
between the nosecone and the prosthetic valve as the prosthetic valve is
pushed through the calcified native leaflets by shielding the distal end
of the prosthetic valve from contacting the native leaflets. Although
FIG. 9 shows the prosthetic valve having a crimped diameter slightly
larger than the diameter of the tapered member 126 at its proximal end,
the tapered member 126 can have a diameter at its proximal end that is
the same as or slightly larger than the diameter of the crimped
prosthetic valve, or at least the same as or slightly larger than the
diameter of the metal frame of the crimped prosthetic valve.

[0108] As shown in FIG. 9, the prosthetic valve desirably is positioned on
the balloon for deployment such that the distal end of the prosthetic
valve is slightly spaced from the nose cone portion 126. When the
prosthetic valve is positioned as shown in FIG. 9, the guide catheter
shaft 22 can be moved proximally relative to the balloon catheter shaft
26 so that the guide catheter shaft is not covering the inflatable
portion of the balloon 28, and therefore will not interfere with
inflation of the balloon.

[0109] As the prosthetic valve 12 is guided through the aortic arch and
into the ascending aorta, the curvature of the steerable section 68 can
be adjusted (as explained in detail above) to help guide or steer the
prosthetic valve through that portion of the vasculature. As the
prosthetic valve is moved closer toward the deployment location within
the aortic annulus, it becomes increasingly more difficult to control the
precise location of the prosthetic valve by pushing or pulling the handle
portion 20 due to the curved section of the delivery apparatus. When
pushing or pulling the handle portion 20, slack is removed from the
curved section of the delivery apparatus before the pushing/pulling force
is transferred to the distal end of the delivery apparatus. Consequently,
the prosthetic valve tends to "jump" or move abruptly, making precise
positioning of the prosthetic valve difficult.

[0110] For more accurate positioning of the prosthetic valve within the
aortic annulus, the prosthetic valve 12 is placed as close as possible to
its final deployment location (e.g., within the aortic annulus such that
an inflow end portion of the prosthetic valve is in the left ventricle
and an outflow end portion of the prosthetic valve is in the aorta) by
pushing/pulling the handle 20, and final positioning of the prosthetic
valve is accomplished using the adjustment knob 84. To use the adjustment
knob 84, the securement mechanism 98 is placed in its locked position, as
described above. Then, the handle 20 is held steady (which retains the
guide catheter shaft 22 in place) while rotating the adjustment knob 84
to move the balloon catheter shaft 26, and thus the prosthetic valve, in
the distal or proximal directions. For example, rotating the knob in a
first direction (e.g., clockwise), moves the prosthetic valve proximally
into the aorta, while rotating the knob in a second, opposite direction
(e.g., counterclockwise) advances the prosthetic valve distally toward
the left ventricle. Advantageously, operation of the adjustment knob 84
is effective to move the prosthetic valve in a precise and controlled
manner without sudden, abrupt movements as can happen when pushing or
pulling the delivery apparatus for final positioning.

[0111] When the prosthetic valve is at the deployment location, the
balloon 28 is inflated to expand the prosthetic valve 12 (as depicted in
FIG. 11) so as to contact the native annulus. The expanded prosthetic
valve becomes anchored within the native aortic annulus by the radial
outward force of the valve's frame against the surrounding tissue.

[0112] The mounting member 124 within the balloon is configured to allow
the inflation fluid (e.g., saline) to flow unobstructed from the proximal
end of the balloon to the distal end of the balloon. As best shown in
FIG. 8, for example, the mounting member 124 comprises a coiled wire
(e.g., a metal coil) having a first section 124a, a second section 124b,
a third section 124c, a fourth section 124d, and a fifth section 124e.
When the prosthetic valve 12 is positioned on the balloon for deployment,
the second section 124b is immediately adjacent the proximal end of the
prosthetic valve and the fourth section 124d is immediately adjacent the
distal end of the prosthetic valve. The first and fifth sections 124a,
124e, respectively, which are at the proximal and distal ends of the
mounting member, respectively, are secured to the balloon catheter shaft.
The second, third, and fourth sections 124b, 124c, and 124d,
respectively, are relatively larger in diameter than the first and fifth
sections and are spaced radially from the outer surface of the balloon
catheter shaft. As can be seen, the second section 124b and the fourth
section 124d are formed with spaces between adjacent coils. The third
section can be formed with smaller spaces (or no spaces) between adjacent
coils to maximize the surface area available to retain the prosthetic
valve on the balloon during final positioning of the prosthetic valve at
the deployment location.

[0113] Referring to FIG. 10, the spacing between coils of the second and
fourth sections 124b, 124d allows the inflation fluid to flow radially
inwardly through the coils of the second section 124b, axially through
the lumen of the third section 124c, radially outwardly through the coils
of the fourth section 124d, into the distal section of the balloon, in
the direction of arrows 128. The nose cone portion 126 also can be formed
with one or more slots 130 that allow the inflation fluid to flow more
easily past the proximal nose cone portion 126 into the distal section of
the balloon. In the illustrated embodiment, the proximal nose cone
portion 126 has three circumferentially spaced slots 130. Since the
inflation fluid can pressurize and inflate the proximal and distal
sections of the balloon at substantially the same rate, the balloon can
be inflated more evenly for controlled, even expansion of the prosthetic
valve.

[0114] FIGS. 12-14 illustrate a mounting member 140 according to another
embodiment. The mounting member 140 comprises a cylindrical inner wall
142, a cylindrical outer wall 144, and a plurality of angularly spaced
ribs 146 separating the inner and outer walls. The inner wall 142 is
secured to the outer surface of the shaft 34 within the balloon. In
particular embodiments, the mounting member 140 can be made of a
relatively rigid material (e.g., polyurethane or another suitable
plastic) that does not radially compress when the prosthetic valve is
moved onto the balloon. As shown in FIG. 16, during inflation of the
balloon, inflation fluid in the proximal section of the balloon can flow
through the spaces 148 between the inner and outer walls of the mounting
member, through one or more slots 130 in the proximal nose cone portion
126, and into the distal section of the balloon, in the direction of
arrows 128.

[0115] It should be noted that the location of the threaded portions of
the adjustment mechanism 82 and the inner shaft 90 can be reversed. That
is, adjustment mechanism 82 can have an externally threaded portion that
engages an internally threaded portion of the inner shaft 90. In
addition, for embodiments where the balloon 28 is initially positioned
proximal to the prosthetic valve 12, the adjustment mechanism 82 can be
used to move the balloon distally relative to the crimped prosthetic
valve in order to center the prosthetic valve on the balloon for
deployment.

[0116] FIGS. 56 and 57 show a prosthetic heart valve 700, according to
another embodiment. The heart valve 700 comprises a frame, or stent, 702
and a leaflet structure 704 supported by the frame. In particular
embodiments, the heart valve 700 is adapted to be implanted in the native
aortic valve and can be implanted in the body using, for example, the
delivery apparatus 10 described above. The prosthetic valve 700 can also
be implanted within the body using any of the other delivery apparatuses
described herein. Thus, the frame 702 typically comprises a plastically
expandable material, such as stainless steel, a nickel based alloy (e.g.,
a nickel-cobalt-chromium alloy), polymers, or combinations thereof. In
other embodiments, the prosthetic valve 12, 700 can be a self-expandable
prosthetic valve with a frame made from a self-expanding material, such
as Nitinol. When the prosthetic valve is a self-expanding valve, the
balloon of the delivery apparatus can be replaced with a sheath or
similar restraining device that retains the prosthetic valve in a
radially compressed state for delivery through the body. When the
prosthetic valve is at the implantation location, the prosthetic valve
can be released from the sheath, and therefore allowed to expand to its
functional size. It should be noted that any of the delivery apparatuses
disclosed herein can be adapted for use with a self-expanding valve.

[0117] FIG. 18 is an exploded, perspective view of the distal end section
of an alternative embodiment of a delivery device, indicated at 10'. The
delivery device 10' shares many similarities with the delivery device 10,
and therefore components of the delivery device 10' that are the same as
those in the delivery device 10 are given the same reference numerals and
are not described further. One difference between the delivery device 10
and the delivery device 10' is that the latter includes a different
mechanism for locking/securing the balloon catheter shaft 26 relative to
the adjustment knob 84.

[0118] Referring to FIGS. 18 and 19, the locking mechanism for the balloon
catheter shaft comprises an adjustment knob 150 housing an inner nut 152,
a washer 154 and a ring 156 disposed inside the inner nut 152, a biasing
member in the form of a coiled spring 158, a pusher element 160, and a
shaft engagement member in the form of a collet 102. As best shown in
FIGS. 20 and 21, the inner nut 152 includes inner threads 162 (FIG. 24)
that engage the external threads of the distal end portion 96 of the
inner shaft 90 (FIG. 22). The pusher element 160 includes a proximal
shaft 164 and an enlarged distal end portion 166 that bears against the
proximal end portion 106 of the collet 102. The spring 158 is disposed on
the shaft 164 of the pusher element 160 and has a proximal end that bears
against the ring 156 and a distal end that bears against the distal end
portion 166 of the pusher element 160.

[0119] Referring to FIGS. 25-27, the adjustment knob 150 is formed with a
plurality of longitudinally extending, circumferentially spaced
projections 168 on the inner surface of the knob. A distal portion of the
knob 150 includes one or more radially extending projections 170 for
gripping by a user and a proximal portion of the knob comprises a
semi-annular portion 172. The knob 150 extends co-axially over the inner
nut 152 with the projections 168 mating with respective grooves 174 on
the outer surface of the nut 152 such that rotation of the knob causes
corresponding rotation of the nut 152.

[0120] The delivery device 10' can be used in the manner described above
in connection with the delivery device 10 to deliver a prosthetic valve
in the vicinity of the implantation site. To restrain movement of the
balloon catheter shaft 26 for fine positioning of the prosthetic valve,
the knob 150 is rotated, which in turn causes rotation of the inner nut
152. The inner nut 152 is caused to translate in the distal direction
along the external threads on the distal end portion 96 of the shaft 90.
As the nut 152 is moved distally, the nut 152 pushes against the ring
156, which in turn pushes against the spring 158. The spring 158 presses
against the distal end portion 166 of the pusher element 160, urging the
pusher element against the collet 102. The pushing force of the pusher
element 160 against the collet causes the fingers 112 of the collet to
frictionally engage the balloon catheter shaft 26, thereby retaining the
balloon catheter shaft relative to the inner shaft 90. In the locked
position, rotation of the adjustment knob 84 causes the inner shaft 90
and the balloon catheter shaft 26 to move axially relative to the guide
catheter shaft 22 (either in the proximal or distal direction, depending
on the direction the knob 84 is rotated).

[0121] The biasing force of the spring 158 desirably is sufficient to lock
the collet against the balloon catheter shaft with a relatively small
degree of rotation of the knob 150, such as less than 360 degrees
rotation of the knob. In the illustrated embodiment, the knob 150 is
rotated less than 180 degrees from an unlocked position (in which the
collet does not retain the balloon catheter shaft) to a locked position
(in which the collet frictionally engages and retains the balloon
catheter shaft). Conversely, rotating the knob 150 in the opposite
direction from the locked position to the unlocked position through the
same degree of rotation allows the spring 158 to release the biasing
force against the pusher element and the collet so as to permit axial
movement of the balloon catheter shaft relative to the collet.

[0122] As best shown in FIG. 21, an indicator ring 176 is disposed on the
shaft 90 adjacent the proximal end of the knob 84. The indicator ring 176
sits within the semi-annular wall 172 of the knob 150 and includes an
indicator tab 178 that extends into the annular space between the ends
180 (FIG. 27) of the semi-annular wall 172. As best shown in FIG. 25, the
outer surface of the knob 150 can include visual indicia that indicate
whether the balloon catheter shaft 26 is in a locked state relative to
the adjustment knob 84. In the illustrated implementation, for example, a
first indicia 182a is located adjacent one end 180 of the semi-annular
wall 172 and a second indicia 182b is located adjacent the other end 180
of the semi-annular wall 172. The first indicia 182a is a graphical
representation of a closed lock (indicating that the balloon catheter
shaft is in a locked state) and the second indicia 182b is a graphical
representation of an open lock (indicating that the balloon catheter
shaft is in an unlocked state). However, it should be understood that the
indicia can take various other forms (text and/or graphics) to indicate
the locked and unlocked states.

[0123] Since the indicator ring 176 is fixed rotationally relative to the
knob 150, the indicator tab 178 limits rotation of the knob 150 through
an arc length defined by the annular space between the ends 180 of the
semi-annular wall 172 (about 170 degrees in the illustrated embodiment).
When the knob 150 is rotated in a first direction (counterclockwise in
the illustrated example), the indicator tab 178 will contact the wall end
180 adjacent indicia 182b and prevent further rotation of the knob 150.
In this position, the collet 102 does not frictionally engage the balloon
catheter shaft 26, which can be moved freely relative to the proximal
handle portion 48. When the knob 150 is rotated in a second direction
(clockwise in the illustrated example), the indicator tab 178 will
contact the wall end 180 adjacent indicia 182a and prevent further
rotation of the knob 150. In this position, the collet 102 is caused to
frictionally engage the balloon catheter shaft in the manner described
above to restrain axial and rotational movement of the balloon catheter
shaft relative to the proximal handle portion 48.

[0124] FIGS. 29-31 show the distal end portion of a balloon catheter 200,
according to another embodiment, that can be used to implant an
intraluminal implant, such as a stent or a stented prosthetic valve. The
features of the balloon catheter 200 can be implemented in the delivery
apparatuses disclosed herein (e.g., apparatus 10 of FIG. 1). In the
figures, a prosthetic valve is shown schematically and is identified by
reference numeral 202. The balloon catheter 200 includes a balloon
catheter shaft 204. The proximal end of the shaft 204 is mounted to a
handle (not shown) and the distal end of the shaft mounts a balloon
assembly 206.

[0125] The balloon assembly 206 comprises an inner balloon 208 disposed
inside an outer balloon 210. The inner balloon 208 is shaped to control
expansion of the prosthetic valve 202 while the outer balloon is shaped
to define the final expanded shape of the prosthetic valve. For example,
as shown in FIG. 30, the inner balloon 208 can have a "dog bone" shape
when inflated, having bulbous end portions that taper inwardly to form a
generally cylindrical center portion of a reduced diameter. The shape of
the inner balloon 208 helps maintain the position of the prosthetic valve
relative to the balloon as the prosthetic valve is expanded due to the
larger end portions that restrict movement of the prosthetic valve in the
axial directions. The distal end portion of the shaft 204 can have
openings to allow an inflation fluid to flow from the lumen of the shaft
204 into the inner balloon 208.

[0126] The inner balloon 208 can be formed with small pores or openings
that are sized to permit suitable inflation of the inner balloon and
allow the inflation fluid to flow outwardly into the space between the
two balloons to inflate the outer balloon, as indicated by arrows 212.
After the inner balloon is inflated, which partially expands the
prosthetic valve 202 (FIG. 30), the inflation fluid begins inflating the
outer balloon 210 (FIG. 31). Inflation of the outer balloon further
expands the prosthetic valve 202 to its final desired shape (e.g.,
cylindrical as shown in FIG. 31) against the surrounding tissue. In such
a two-stage expansion of the prosthetic valve 202, the position of the
prosthetic valve relative to the shaft 204 can be controlled due to the
inner balloon, which limits axial movement of the prosthetic valve during
its initial expansion.

[0127] In an alternative embodiment, in lieu of or in addition to the
pores or holes in the inner balloon, the inner balloon can be configured
to burst at a predetermined pressure (e.g., 1-5 bars) after it is
inflated to a desired size. After the inner balloon ruptures, the
inflation fluid can begin inflating the outer balloon.

[0128]FIG. 32 discloses a delivery system 300, according to another
embodiment, that can be used to implant an expandable prosthetic valve.
The delivery system 300 is specifically adapted for use in introducing a
prosthetic valve into a heart in a transapical procedure, which is
disclosed in co-pending application Ser. No. 12/835,555, filed Jul. 13,
2010 (U.S. Publication No. 2011/0015729), which is incorporated herein by
reference. In a transapical procedure, a prosthetic valve is introduced
into the left ventricle through a surgical opening in the apex of the
heart. The delivery system 300 similarly can be used for introducing a
prosthetic valve into a heart in a transaortic procedure. In a
transaortic procedure, a prosthetic valve is introduced into the aorta
through a surgical incision in the ascending aorta, such as through a
partial J-sternotomy or right parasternal mini-thoracotomy, and then
advanced through the ascending aorta toward heart.

[0129] The delivery system comprises a balloon catheter 302, an introducer
304, and a loader 306. The balloon catheter 302 comprises a handle 308,
an outer flush shaft 310 extending from the handle, an articulating main
shaft 312 extending from the handle 308 coaxially through the outer shaft
310, an inner shaft 313 extending from the handle coaxially through the
articulating shaft 312, an inflatable balloon 314 mounted on the shaft
312, and a nose cone 316 mounted on the inner shaft 313 distal to the
balloon.

[0130] As best shown in FIG. 33, a pusher element, or stop member, 318 is
mounted on the shaft 312 within the proximal portion of the balloon and
the nose cone is formed with a stop member 320 that extends into the
distal portion of the balloon. The spacing between the distal end of the
pusher element 318 and the proximal end of the stop member 320 defines an
annular space sized to partially receive a prosthetic valve that is
crimped on the balloon. In use, the prosthetic valve is crimped onto the
balloon between the pusher element 318 and the stop member 320 such that
the proximal end of the prosthetic valve can abut the pusher element and
the distal end of the prosthetic valve can abut the stop member (depicted
in the embodiment shown in FIG. 47A). In this manner, these two elements
assist in retaining the position of the prosthetic valve on the balloon
as it is inserted through the introducer 304.

[0131] As shown in FIG. 32, the introducer 304 comprises an introducer
housing 322 and a distal sheath 324 extending from the housing 322. The
introducer 304 is used introduce or insert the balloon catheter 302 into
a patient's body. As shown in FIG. 34, the introducer housing 322 houses
one or more valves 326 and includes a proximal cap 328 for mounting the
loader. The loader 306 provides a coupling between the balloon catheter
and the introducer. The loader 306 includes two retaining arms 330 that
engage the proximal cap 328 of the introducer. The manner of using a
loader to assist in inserting a balloon catheter and prosthetic valve
into an introducer is described below with respect to the embodiment
shown in FIGS. 51-53.

[0132] The construction of the handle 308 is shown in FIGS. 36-39. The
handle 308 includes a housing 332, which houses a mechanism for effecting
controlled deflection, or articulation, of balloon catheter shaft 312.
The mechanism in the illustrated embodiment comprises a shaft 334, a
sliding mechanism 336, a spring 338, and proximal and distal rack gears
340, 342, respectively. The proximal end portion of the shaft 334 is
formed with external threads that engage internal threads of two threaded
nuts 364a, 364b inside the handle. The shaft 334 can rotate within the
handle but is restricted from translational movement within the handle.
The nuts 364 desirably have opposite threads and are disposed on
respective portions of the shaft 334 that have corresponding external
threads. For example, the proximal nut 364a can have left-handed threads
and is disposed on left-handed threads on the shaft, while the distal nut
364b can have right-handed threads and is disposed on right-handed
threads on the shaft. This causes the nuts 364 to translate in opposite
directions along the threads of the shaft 334 upon its rotation. As best
shown in FIG. 39, each nut 364 has a pair of radially extending flanges
380 on diametrically opposite sides of the nut. The inside of the housing
is formed with a pair of elongated slots 382 (one of which is shown in
FIG. 39) on opposing inside surfaces of the housing. The opposing flanges
380 on each nut 364 can extend into respective slots 382, which prevent
rotation of the nuts upon rotation of the shaft 334. In this manner, the
nuts 364 are caused to move lengthwise of the shaft 334 upon its
rotation.

[0133] The distal end portion of the shaft 334 supports a proximal spur
gear 344, a distal spur gear 346, a proximal clutch 348, and a distal
clutch 350. The shaft 334 has a flat 366 that engages corresponding flats
on center bores of the clutches 348, 350, which provides for rotation of
the shaft when one of the clutches is engaged and rotated by a respective
spur gear, as described below. The sliding mechanism 336 includes a
user-engageable actuator 352, an elongate arm 354 extending from actuator
352, and proximal and distal rings 356, 358, respectively, mounted on the
distal end portion of the arm 354. Mounted on the shaft 334 and held
between the rings is a coil spring 360.

[0134] Two pull wires (not shown) extend from the handle through the
balloon catheter shaft 312 on diametrically opposite sides of the balloon
catheter shaft to its distal end portion. A first pull wire has a
proximal end secured to the proximal nut 364a inside the handle and a
distal end that is secured to the distal end portion of the balloon
catheter shaft 312. A second pull wire has a proximal end secured to the
distal nut 364b inside the handle and a distal end that is secured to the
distal end portion of the balloon catheter shaft 312 on a diametrically
opposite side from the securement location of the first pull wire.

[0135] The housing 332 is configured to actuate the deflection
(articulation) mechanism inside the handle when it is squeezed by the
hand of a user. For example, the housing 332 can comprise a lower housing
section 368 and an upper housing section 370, which can be comprised of
two separable housing sections 370a, 370b for ease of assembly. Referring
to FIG. 36, the lower housing section 368 is mounted to the upper housing
section 370 in a manner that permits the two sections to move toward and
apart from each other a limited distance when squeezed by a user's hand,
as indicated by arrow 374. The torsion spring 338 has one arm 376a that
bears against the inner surface of the upper housing portion 370 and
another arm 376b that bears against the inner surface of the lower
housing portion 368 to resiliently urge the two housing portions apart
from each other. As such, squeezing the handle moves the upper and lower
housing portions together and releasing manual pressure allows the
housing portions to move apart from each other a limited amount under the
spring force. In an alternative embodiment, a portion of the housing can
be made of a flexible or deformable material that can deform when
squeezed by the hand of a user in order to actuate the deflection
mechanism.

[0136] The deflection mechanism works in the following manner. Squeezing
the handle 332 causes the rack gears 340, 342 to move in opposite
directions perpendicular to shaft 334 (due to movement of the upper and
lower housing sections), which in turn causes rotation of the
corresponding spur gears 344, 346 in opposite directions. The sliding
mechanism 336 can be manually moved between a proximal position, a
neutral (intermediate) position, and a distal position. When the sliding
mechanism is in the neutral position (FIG. 36), the clutches are
disengaged from their respective spur gears, such that rotation of the
spur gears does not rotate the shaft 334. However, sliding the sliding
mechanism 336 distally to a distal position pushes the coil spring 360
against the distal clutch 350 to engage the distal spur gear 346. While
the sliding mechanism is held in the distal position, the handle is
squeezed and the resulting rotation of the distal spur gear 346 is
transmitted to the shaft 334 to rotate in the same direction, which in
turn causes the nuts 364 to move in opposite directions along the shaft
334 (e.g., toward each other). Translation of the nuts 364 in opposite
directions applies tension to the first pull wire and introduces slack to
the second pull wire, causing the balloon catheter shaft 312 to bend or
deflect in a first direction. The face of the clutch 350 that engages
spur gear 346 is formed with teeth 362 that cooperate with corresponding
features of the gear to rotate the clutch and shaft 334 when the handle
is squeezed, and allow the gear to spin or rotate relative to the clutch
when manual pressure is removed from the handle. In this manner, the
balloon catheter shaft bends a predetermined amount corresponding to each
squeeze of the handle. The deflection of the balloon catheter shaft can
be controlled by repeatedly squeezing the handle until the desired degree
of deflection is achieved.

[0137] The balloon catheter shaft 312 can be deflected in a second
direction, opposite the first direction by sliding the sliding mechanism
336 in the proximal direction, which pushes the coil spring 360 against
the proximal clutch 348 to engage the proximal spur gear 344. While
holding the sliding mechanism in the proximal position and squeezing the
handle, the proximal spur gear 344 rotates the proximal clutch 348 in the
same direction. Rotation of the proximal clutch is transmitted to the
shaft 334 to rotate in the same direction, resulting in translation of
the nuts 364 in opposite directions (e.g., if the nuts move toward each
other when the sliding mechanism is in the distal position, then the nuts
move away from each other when the sliding mechanism is in the proximal
position). The proximal clutch 348 is similarly formed with teeth 362
that engage the proximal spur gear 344 and cause rotation of the proximal
clutch and shaft 334 only when the handle is squeezed but not when
manually pressure is removed from the handle. In any case, movement of
the threaded nuts 364 applies tension to the second pull wire and
introduces slack to the first pull wire, causing the balloon catheter
shaft 312 to bend in the opposite direction.

[0138] FIGS. 40-42 show an alternative embodiment of a handle, indicated
at 400, that can be incorporated in the balloon catheter 302 (in place of
handle 308). The handle 400 comprises a housing 402, which can be formed
from two halves 402a, 402b for ease of assembly. Two wheels, or rotatable
knobs, 404a, 404b are positioned on opposite sides of the handle. The
knobs are mounted on opposite ends of a shaft 406 having gear teeth 408.
A rotatable, hollow cylinder 410 extends lengthwise inside of the handle
in a direction perpendicular to shaft 406. The cylinder 410 includes
external gear teeth 412 that engage the gear teeth 408 on shaft 406. The
inner surface of the cylinder 410 is formed with internal threads 414,
which can include right-handed and left-handed threads. A proximal
threaded nut 416a and a distal threaded nut 416b are disposed inside of
the cylinder 410 and are mounted for sliding movement on a rail 418 that
extends co-axially through the cylinder. The nuts 416a, 416b have
external threads that are threaded in opposite directions and engage the
corresponding right-handed and left-handed threads on the inner surface
of the cylinder 410. The rail 418 has a flat 420 that engages
corresponding flats on the inner bores of the nuts 416a, 416b, which
allows the nuts to translate along the length of the rail without
rotating.

[0139] First and second pull wires (not shown) are provided and secured to
respective nuts 416a, 416b and the distal end of the balloon catheter
shaft 312 as previously described. Deflection of the balloon catheter
shaft 312 in first and second opposing directions can be accomplished by
rotating the knobs 404a, 404b (which rotate together) clockwise and
counterclockwise. For example, rotating the knobs clockwise produces
rotation of the cylinder 410 via gear teeth 408 engaging gear teeth 412.
Rotation of cylinder 410 causes the nuts 416a, 416b to move in opposite
directions along the rail 418 (e.g., toward each other). Translation of
the nuts in opposite directions applies tension to the first pull wire
and introduces slack to the second pull wire, causing the balloon
catheter shaft 312 to bend or deflect in a first direction. Rotating the
knobs counterclockwise produces rotation of the cylinder 410 in a
direction opposite its initial rotation mentioned above. Rotation of
cylinder 410 causes the nuts 416a, 416b to move in opposite directions
along the rail 418 (e.g., away each other). Translation of the nuts in
opposite directions applies tension to the second pull wire and
introduces slack to the first pull wire, causing the balloon catheter
shaft 312 to bend or deflect in a second direction, opposite the first
direction.

[0140] The handle 400 can optionally include a pusher actuation mechanism
422 that is configured to move a pusher device adjacent the distal end of
the balloon catheter. The pusher device extends partially over the
balloon and holds the prosthetic valve in place on the balloon as the
prosthetic valve and balloon catheter are inserted through the
introducer. A pusher device is disclosed in co-pending application Ser.
No. 12/385,555, which is incorporated herein by reference. The actuation
mechanism 422 is pivotably connected to a linkage arm 424, which in turn
is pivotably connected to a proximal holder 426 of the pusher device (not
shown). The pusher device can extend from the proximal holder 426 to the
balloon 314. Moving the actuation mechanism 422 to a distal position
moves the pusher device in a position partially extending over the
balloon 314 and holding the prosthetic valve in place on the balloon for
insertion through the introducer 304. Moving the actuation mechanism 422
to a proximal position moves the pusher device proximally away from the
balloon and the prosthetic valve once inside the heart so that the
balloon can be inflated for deployment of the prosthetic valve. If a
movable pusher device is not used (as in the illustrated balloon catheter
302), then the pusher actuation mechanism 422 would not be needed. For
example, in lieu of or in addition to such a pusher device, stop members
318, 320 inside the balloon can be used to retain the position of the
prosthetic valve on the balloon (FIGS. 33 and 47A).

[0141] FIGS. 43-45 show another embodiment of a handle, indicated at 500,
that can be incorporated in the balloon catheter 302 (in place of handle
308). The handle 500 comprises a housing 502, which can be formed from
multiple housing sections, including first and second distal housing
portions 504, 506, respectively, that form a distal housing space, and
first and second proximal housing portions 508, 510, respectively, that
form a proximal housing space. The housing houses a proximal cylinder 512
and a distal cylinder 514, which house proximal and distal nuts 516, 518,
respectively. The nuts are disposed on a rail 520 that extends co-axially
through the cylinders 512, 514. The cylinders 512, 514 have opposing
internal threads, e.g., the proximal cylinder can have right-handed
threads and the distal cylinder can have left-handed threads. The
cylinders 512, 514 are secured to each other end-to-end (e.g., with a
frictional fit between the distal end of the proximal cylinder and the
proximal end of the distal cylinder) so that both rotate together. In
other embodiments, the cylinders 512, 514 can be formed as a single
cylinder having left-handed and right-handed threads as used in the
handle 400 described above.

[0142] A user-engageable, rotatable knob 522 is mounted on the outside of
the housing 502 and engages the proximal cylinder 512 (e.g., through an
annular gap in the housing) such that rotation of the knob 522 causes
corresponding rotation of the cylinders 512, 514. The deflection
mechanism of this embodiment works in a manner similar to that shown in
FIGS. 40-42 to alternatively apply tension and introduce slack in first
and second pull wires (not shown) secured to the nuts 516, 518,
respectively. For example, rotating the knob 522 in a first direction
causes the nuts to translate in opposite directions along the rail 520
(e.g., toward each other), which is effective to apply tension to the
first pull wire and introduce slack to the second pull wire, causing the
balloon catheter shaft 312 to bend or deflect in a first direction.
Rotating the knob 522 in a second direction causes the nuts to translate
in opposite directions (e.g., away from each other), which is effective
to apply tension to the second pull wire and introduce slack to the first
pull wire, causing the balloon catheter shaft 312 to bend or deflect in a
second direction, opposite the first bending direction.

[0143]FIG. 46 discloses a delivery apparatus 600, according to another
embodiment, that can be used to implant an expandable prosthetic heart
valve. The delivery apparatus 600 is specifically adapted for use in
introducing a prosthetic valve into a heart in a transapical or
transaortic procedure. A delivery system for implanting a prosthetic
heart valve can comprise the delivery apparatus 600, an introducer 602
(FIGS. 49-50), and a loader 604 (FIGS. 51-52).

[0144] Referring to FIGS. 46-47, the delivery apparatus 600 in the
illustrated form is a balloon catheter comprising a handle 606, a
steerable shaft 608 extending from the handle 606, an inner shaft 610
extending from the handle 606 coaxially through the steerable shaft 608,
an inflatable balloon 612 extending from the distal end of the steerable
shaft 608, a proximal shoulder, or stop member, 614 extending from the
distal end of the steerable shaft 608 into the proximal end region of the
balloon, a nose cone 616 mounted on the distal end of the inner shaft
610, and a distal shoulder, or stop member, 618 mounted on the inner
shaft 610 within the distal end region of the balloon. The distal stop
member 618 can be an integral extension of the nose cone 616 as shown.
The proximal stop member 614 can have a proximal end portion 620 secured
to the outside surface of the distal end portion of the steerable shaft
608. The balloon 612 can have a proximal end portion 622 and a distal end
portion 624, with the proximal end portion 622 being secured to the outer
surfaces of the shaft 608 and/or the end portion 620 of the proximal stop
614 and the distal end portion 624 being secured to the outer surface of
a distal end portion 626 of the distal stop member 618.

[0145] As best shown in FIG. 47, the proximal end portion 620 of the
proximal stop member 614 includes one or more openings 646 for inflation
fluid formed in the annular wall between the outer surface of the inner
shaft 610 and the inner surface of the outer shaft 608. The openings 646
allow inflation fluid to flow outwardly from the space between the inner
shaft 610 and the outer shaft 608 into the balloon in the distal
direction.

[0146] The proximal stop member 614 has a distal end portion 628 in form
of a substantially cone-shaped member, and the distal stop member 618 has
a proximal end portion 630 of the same shape. The spacing between the
cone-shaped members 628, 630 defines an annular space sized to at least
partially receive a prosthetic valve that is crimped on the balloon. In
use, as shown in FIG. 47A, the prosthetic valve 12 is crimped onto the
balloon between the cone-shaped members 628, 630 such that the prosthetic
valve is retained on the balloon between the cone-shaped members as the
prosthetic valve is advanced through the introducer. Desirably, the
spacing between the cone-shaped members 628, 630 is selected such that
the prosthetic valve is slightly wedged between the cone-shaped members
with the non-inflated balloon extending between the proximal end of the
prosthetic valve and the proximal member 628 and between the distal end
of the prosthetic valve and the distal member 630. In addition, the
maximum diameter of the members 628, 630 at their ends adjacent the ends
of the prosthetic valve desirably is about the same as or slightly
greater than the outer diameter of the frame of the prosthetic valve 12
when crimped onto the balloon.

[0147] As further shown in FIG. 47, each of the cone-shaped members 628,
630 desirably is formed with one or more slots 632. In the illustrated
embodiment, each of the cone-shaped members 628, 630 has three such slots
632 that are equally angularly spaced in the circumferential direction.
The slots 632 facilitate radial compression of the cone-shaped members
628, 630, which is advantageous during manufacturing of the delivery
device and during crimping of the prosthetic valve. In particular, the
proximal and distal ends 622, 624 of the balloon may be relatively
smaller than the maximum diameter of the cone-shaped members 628, 630.
Thus, to facilitate insertion of the cone-shaped members 628, 630 into
the balloon during the assembly process, they can be radially compressed
to a smaller diameter for insertion into the balloon and then allowed to
expand once inside the balloon. When the prosthetic valve is crimped onto
the balloon, the inside surfaces of the crimping device (such as the
surfaces of crimping jaws) may contact the cone-shaped members 628, 630
and therefore will radially compress the cone-shaped members along with
the prosthetic valve. Typically, the prosthetic valve will undergo a
small amount of recoil (radial expansion) once removed from the crimping
device. Due to the compressibility cone-shaped members 628, 630, the
prosthetic valve can be fully compressed to a crimped state in which the
metal frame of the prosthetic valve has an outer diameter equal to or
less than the maximum diameter of the cone-shaped members (accounting for
recoil of the prosthetic valve).

[0148] The slots 632 in the cone-shaped members 628, 630 also allow
inflation fluid to flow radially inwardly through the cone-shaped members
and through the region of the balloon extending through the crimped
prosthetic valve in order to facilitate expansion of the balloon. Thus,
inflation fluid can flow from a proximal region of the balloon, inwardly
though slots 632 in proximal stop member 628, through the region of the
balloon extending through the prosthetic valve, outwardly through slots
632 in distal stop 630, and into a distal region of the balloon. Another
advantage of the distal stop member 618 is that it serves a transition
region between the nose cone and the prosthetic valve. Thus, when the
prosthetic valve is advanced through the leaflets of a native valve, the
distal stop member 618 shields the distal end of the prosthetic valve
from contacting the surrounding tissue, which can otherwise dislodge or
prevent accurate positioning of the prosthetic valve prior to deployment.

[0149] The construction of the handle 606 is shown in FIG. 48. The handle
606 comprises a housing 634, which can be formed from multiple housing
sections. The housing 634 houses a mechanism for effecting controlled
articulation/deflection of the shaft 608. The mechanism in the
illustrated embodiment comprises a threaded shaft 636, and a threaded nut
638 disposed on the shaft. The proximal end portion of the shaft 636 is
formed with external threads that engage internal threads of the threaded
nut 638. The shaft 636 can rotate within the handle but is restricted
from translational movement within the handle. The nut 638 has opposing
flanges 640 (one of which is shown in FIG. 48), which extend into
respective slots formed on the inside surfaces of the housing to prevent
rotation of the nut. In this manner, the nut 638 translates along the
threads of the shaft 636 upon rotation of the shaft.

[0150] The distal end portion of the shaft 636 supports user-engageable,
rotatable knob 642. The shaft 636 is coupled to the knob 12 such that
rotation of the knob causes corresponding rotation of the shaft 636. A
pull wire 644 extends from the handle through the balloon catheter shaft
608 on one side of the balloon catheter shaft to its distal end portion.
The pull wire 644 has a proximal end secured to the threaded nut 638
inside the handle and a distal end that is secured to the distal end
portion of the balloon catheter shaft 608. The articulation mechanism of
this embodiment works by rotating the knob 642 in one direction, which
causes the threaded nut 638 to translate along the shaft 636, which is
effective to apply tension to the pull wire causing the balloon catheter
shaft 608 to bend or articulate in a predetermined direction. Rotating
the knob 642 in the opposite direction causes to the nut 638 to translate
in the opposite direction, thereby releasing tension in the pull wire,
which allows the shaft 608 to deflect in the opposite direction under its
own resiliency. In alternative embodiments, another threaded nut and
respective pull wire can be provided in the housing to allow for
bi-directional steering of the shaft 608, as described above in
connection with the embodiments of FIGS. 36-45.

[0151]FIG. 49 is a perspective view of the introducer 602, which
comprises an introducer housing assembly 650 and a sheath 652 extending
from the housing assembly 650. The introducer 602 is used to introduce or
insert the delivery apparatus 600 into a patient's body. In a transapical
procedure, for example, the sheath 652 is inserted through surgical
incisions in the chest and the apex of the heart to position the distal
end of the sheath in the left ventricle (such as when replacing the
native aortic valve). The introducer 602 serves as a port or entry point
for inserting the delivery apparatus into the body with minimal blood
loss. As shown in FIG. 50, the introducer housing 650 houses one or more
valves 654, and includes a distal cap 656 to secure sheath 652 to the
housing 650 and a proximal cap 658 for mounting the loader 604.

[0152] FIGS. 51-52 are respective and cross-sectional views of the loader
604, which is used to protect the crimped prosthesis during insertion
into the introducer 602. The loader 604 in the illustrated configuration
comprises a distal loader assembly 660 and a proximal loader assembly
662. The distal loader assembly 660 and proximal loader assembly 662 can
be secured to each other by mating female and male threads 680 and 682,
respectively. The distal loader assembly 660 comprises a loader tube 664
and a loader distal cap 666. The proximal loader assembly 662 comprises a
loader housing 668, a button valve 670, a washer 672, two disc valves
674, and a proximal loader cap 676. The distal loader cap 666 can be
formed with a lip 684 that is configured to engage the proximal cap 658
of the introducer 602 as shown in FIG. 53.

[0153] In use, the proximal loader assembly 662 (apart from the distal
loader assembly 660) can be placed on the balloon catheter shaft 608
prior to placing the prosthetic valve on the balloon and the crimping the
prosthetic valve to avoid passing the crimped prosthetic valve through
the sealing members 674 inside the housing 668. After the prosthetic
valve is crimped onto the balloon, the distal loader assembly 660 is slid
over the crimped prosthetic valve and secured to the proximal loader
assembly 662 (by screwing threads 682 into threads 680). As shown in FIG.
53, the loader tube 664 (while covering the crimped prosthetic valve) can
then be inserted into and through the introducer housing 650 so as to
extend through the internal sealing members 654 (FIG. 50). The loader
tube 664 therefore prevents direct contact between the sealing members
654 of the introducer and the crimped prosthetic valve. The loader 604
can be secured to the introducer 602 by pressing the annular lip 684 of
the loader into the proximal cap 658 of the introducer. After insertion
of the loader tube into the introducer, the prosthetic valve can be
advanced from the loader tube, through the sheath 652, and into a region
with the patient's body (e.g., the left ventricle).

[0154] As best shown in FIG. 53, the proximal cap 658 of the introducer
comprises first and second diametrically opposed ribbed portions 694 and
first and second diametrically opposed, deflectable engaging portions 696
extending between respective ends of the ribbed portions. When the loader
604 is inserted into the introducer 602, the lip 684 of the loader snaps
into place on the distal side of the engaging portions 696, which hold
the loader in place relative to the introducer. In their non-deflected
state, the ribbed portions 694 are spaced slightly from the adjacent
surfaces of the cap 666 of the loader. To remove the loader from the
introducer, the ribbed portions 694 are pressed radially inwardly, which
causes the engaging portions 696 to deflect outwardly beyond the lip 684,
allowing the loader and the introducer to be separated from each other.

[0155] Fluid (e.g., saline) can be injected into the loader 604 through a
lured port 678, which when pressurized by fluid will allow for fluid flow
in a single direction into the loader housing. Alternatively, fluid
(e.g., blood, air and/or saline) can be removed from the loader 604 by
depressing the crossed portion of the button valve 670, which creates an
opening between the valve 670 and the loader housing. As best shown in
FIGS. 52 and 54, the button 670 in the illustrated embodiment comprises
an elastomeric annular ring 686 and a user-engageable projection 688 that
extends outwardly through an opening 690 in the loader housing 668. The
ring 686 seals the opening 690 and another opening 692 in the loader
housing that communicates with the port 678. When a pressurized fluid is
introduced into the port 678, the pressure of the fluid causes the
adjacent portion of the ring 686 to deflect inwardly and away from its
position sealing opening 692, allowing the fluid to flow into the loader.
Alternatively, to remove fluid from the loader, a user can depress
projection 688, which causes the adjacent portion of the ring 686 to
deflect inwardly and away from its position sealing the opening 690,
allowing fluid in the loader to flow outwardly through the opening 690.

General Considerations

[0156] For purposes of this description, certain aspects, advantages, and
novel features of the embodiments of this disclosure are described
herein. The disclosed methods, apparatuses, and systems should not be
construed as limiting in any way. Instead, the present disclosure is
directed toward all novel and nonobvious features and aspects of the
various disclosed embodiments, alone and in various combinations and
sub-combinations with one another. The methods, apparatuses, and systems
are not limited to any specific aspect or feature or combination thereof,
nor do the disclosed embodiments require that any one or more specific
advantages be present or problems be solved.

[0157] Although the operations of some of the disclosed methods are
described in a particular, sequential order for convenient presentation,
it should be understood that this manner of description encompasses
rearrangement, unless a particular ordering is required by specific
language. For example, operations described sequentially may in some
cases be rearranged or performed concurrently. Moreover, for the sake of
simplicity, the attached figures may not show the various ways in which
the disclosed methods can be used in conjunction with other methods. As
used herein, the terms "a", "an" and "at least one" encompass one or more
of the specified element. That is, if two of a particular element are
present, one of these elements is also present and thus "an" element is
present. The terms "a plurality of" and "plural" mean two or more of the
specified element.

[0158] As used herein, the term "and/or" used between the last two of a
list of elements means any one or more of the listed elements. For
example, the phrase "A, B, and/or C" means "A," "B," "C," "A and B," "A
and C," "B and C" or "A, B and C."

[0159] As used herein, the term "coupled" generally means physically
coupled or linked and does not exclude the presence of intermediate
elements between the coupled items absent specific contrary language.

[0160] In view of the many possible embodiments to which the principles of
the disclosed invention may be applied, it should be recognized that the
illustrated embodiments are only preferred examples of the invention and
should not be taken as limiting the scope of the invention. Rather, the
scope of the invention is defined by the following claims. We therefore
claim as our invention all that comes within the scope and spirit of
these claims.